| Scientific Title of Trial | Study of efficacy between two combinations of herbal medicine (amukkirai chooranam / vellarugu chooranam with thalangai ennai) in the treatment of knee osteoarthritis | |
| Public Title of Trial (in lay language) | Study of the combination of amukkirai chooranam with thalangai ennai and vellarugu chooranam with thalangai ennai in the treatment of knee osteoarthritis | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Knee osteoarthritis | |
| What is the research question being addressed? | Which combination of herbal medicine: amukkirai chooranam with thalangai ennai or vellarugu chooranam with thalangai ennai is more efficacious in the treatment of knee osteoarthritis? | |
| Study design | Open labeled, Randomised, parallel group trial | |
| Intervention(s) planned | Patients will be recruited for the trial following qualitative and quantitative analysis of the trial medicines (Amukkirai and Vellarugu chooranam) and a pilot study. Subjects for the clinical trial will be selected from Out Patients Department (O.P.D.) and Indoor Patients Department (I.P.D.) of Ayurvedic Hospitals / Dispensaries in Jaffna District. Eligible patients with knee osteoarthritis will be randomized in a 1:1 ratio to the treatment arms. The prescribed dose is two capsules thrice a day with lukewarm water after meals. The daily dose of experimental medicine is 3g (Each capsule contains 500mg of trial plant materials) and local applications of oil {10ml} twice a day for one mandalam (40 days). Subjects will be requested to refrain from other alternative medicinal therapy (allopathic, homeopathy, acupuncture, and acupressure, etc.) during the study period. | |
| Inclusion criteria | 1. Subjects suffering from knee osteoarthritis diagnosed based on history, clinical examination findings and classical radiological findings, and fulfilling the American College of Rheumatology (ACR) classification criteria 2. Age above 40 years 3. Pain visual analogue score (VAS) > 4 in one or both the knees while performing a weight bearing activity 4. Ambulant and require analgesic for pain relief and / or not satisfied with ongoing analgesic drugs and seeking a change. | |
| Exclusion criteria | 1. Subjects with non-degenerative joint diseases or other joint diseases such as Āma vāta (rheumatoid arthritis), Kazhugazha vāta, (psoriatic arthritis), Piramega vāta (gonococcal arthritis), Narithalai vāta (haemo arthritis) 2. Subjects with severe disabling arthritis and / or bedridden. 3. History of intra-articular knee injection within the month preceding the study 3. Severe unstable renal, hepatic, diabetic, haemopoietic, malignant, hypertensive, cardiac disorder and mentally affected as revealed by history and / or investigation. 4. Subject taking antipyretics, analgesics, tranquilizers, hypnotics, alcohol, or any other drug which would interfere with pain perception and need for other drug therapy for arthritis 5. Women who are pregnant, lactating 6. Those unwilling to come for regular follow-up for the entire duration of the study. | |
| Target number / sample size | 300 | |
| Primary outcome(s) | 1.Traditional clinical parameters {Prakriti assessment, eight fold examination and six fold source of knowledge} 2.Clinical parameters: gait, knee joint pain {Visual Analogue Scale (VAS)}, stiffness, tenderness on knee joint, knee joint swelling, muscular wasting (a tape measure), local crepitation, walking time, restriction of knee joint movement, range of knee joint movements (Goniometer assessment), knee joint deformities and muscular power. |
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| Primary outcome(s) - time of assessment(s) | At baseline, 10th, 20th, 30th, 40th days, and on follow-up assessment at the end of one month and two months. | |
| Secondary outcome(s) | 1. The effect of morbidity status on health related quality of life in subjects will be measured by the WOMAC questionnaire, goniomter assessment and Visual analogue Scale. Questionnaire will be used to assess pain, stiffness and physical functions depending on score basis. Movements and pain will be measured by goniometer and VAS scale respectively. 2. Routine laboratory workup (haemoglobin, White blood cell - total and differential count, Erythrocyte sedimentation rate, Rheumatoid factor assays, Liver function test and Kidney function test} and X-rays of knees |
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| Secondary outcome(s) - time of assessment(s) | At baseline and immediately after end of therapy (40th day) then follow-up period at the end of one month and two months. | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 18/09/2012 | |
| Anticipated end date | 01/01/2015 | |
| Recruitment status | Select Status | |
| State of ethics review approval | Approved by the Faculty of Medicine, University of Jaffna | |
| Funding source(s) | Scholarship award for M’Phil / PhD, Higher Education for the Twenty first Century (HETC) Project, Ministry of Higher Education, Sri Lanka | |
| Applicant's Email | vsanmuga07@gmail.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr. (Miss) Vinotha Sanmugarajah
Lecturer (Probationary) Unit of Siddha Medicine, University of Jaffna, Kaithady 0777490634 - vsanmuga07@gmail.com |
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| Primary Study Sponsor/ Organization | HETC Project, Ministry of Higher Education, Sri Lanka.
23/135 Diyawanna Gardens, Chandra Silva MW, Nugegoda 0094 11 2814279 0094 11 2814283 hrd@hetc.lk www.hetc.lk/ |
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| Contact Person for Public Queries | Dr. (Mrs) Sri Ranjani Sivapalan (supervisor) Senior Lecturer Gr.I Unit of Siddha Medicine, University of Jaffna, Kaithady 0777171656 / 0212225673 - saisiva7@yahoo.co.in |
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| Secondary Study Sponsor(s), (if any) | - - - |
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